NDC 17856-6312

cough dm

Dextromethorphan Polistirex

cough dm is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Atlantic Biologicals Corp.. The primary component is Dextromethorphan Hydrobromide.

Product ID17856-6312_3eba5ef5-8a7f-4f73-86ec-91dbf9ec924f
NDC17856-6312
Product TypeHuman Otc Drug
Proprietary Namecough dm
Generic NameDextromethorphan Polistirex
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2012-09-06
Marketing CategoryANDA / ANDA
Application NumberANDA091135
Labeler NameATLANTIC BIOLOGICALS CORP.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength30 mg/5mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 17856-6312-1

5 mL in 1 CUP (17856-6312-1)
Marketing Start Date2021-01-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-6312-1 [17856631201]

cough dm SUSPENSION
Marketing CategoryANDA
Application NumberANDA091135
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-22
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

OpenFDA Data

SPL SET ID:73aede9d-37dd-4aa5-a906-0e0c94cecff1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1373045
  • NDC Crossover Matching brand name "cough dm" or generic name "Dextromethorphan Polistirex"

    NDCBrand NameGeneric Name
    0363-0384Cough DMdextromethorphan polistirex
    0363-0494Cough DMdextromethorphan polistirex
    0363-0958Cough DMdextromethorphan polistirex
    0904-6312cough dmdextromethorphan polistirex
    11822-0384Cough DMdextromethorphan polistirex
    11822-0494Cough DMdextromethorphan polistirex
    11822-0958Cough DMCough DM
    17856-6312cough dmcough dm
    30142-384Cough DMCough DM
    30142-494cough dmcough dm
    30142-958Cough DMCough DM
    37012-384Cough DMCough DM
    37808-384Cough DMCough DM
    41250-384Cough DMCough DM
    41250-494Cough DMCough DM
    41250-958Cough DMCough DM
    42507-384cough dmcough dm
    42507-958Cough DMCough DM
    56062-384Cough DMCough DM
    59779-384Cough DMCough DM
    59779-709Cough DMCough DM
    59779-958Cough DMCough DM
    0113-7384basic care cough DMdextromethorphan polistirex
    0363-0899childrens cough dmDextromethorphan polistirex
    0031-8725Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8726Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0113-0384good sense cough dmdextromethorphan polistirex
    0113-0958Good Sense Cough DMdextromethorphan polistirex
    0031-8655Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8753Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8754Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8755Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    11673-114up and up 12 hour cough reliefdextromethorphan polistirex

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.